The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Fassier-duval Telescopic Im System.
| Device ID | K211292 |
| 510k Number | K211292 |
| Device Name: | Fassier-Duval Telescopic IM System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Pega Medical Inc. 1111 Autoroute Chomedey Laval, CA H7w 5j8 |
| Contact | Enrique Garcia |
| Correspondent | Enrique Garcia Pega Medical Inc. 1111 Autoroute Chomedey Laval, CA H7w 5j8 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2021-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540194013422 | K211292 | 000 |
| 07540194013286 | K211292 | 000 |
| 07540194013279 | K211292 | 000 |
| 07540194013262 | K211292 | 000 |
| 07540194013255 | K211292 | 000 |
| 07540194013248 | K211292 | 000 |
| 07540194013231 | K211292 | 000 |
| 07540194013224 | K211292 | 000 |
| 07540194013217 | K211292 | 000 |
| 07540194013200 | K211292 | 000 |
| 07540194013194 | K211292 | 000 |
| 07540194013293 | K211292 | 000 |
| 07540194013309 | K211292 | 000 |
| 07540194013316 | K211292 | 000 |
| 07540194013415 | K211292 | 000 |
| 07540194013408 | K211292 | 000 |
| 07540194013392 | K211292 | 000 |
| 07540194013385 | K211292 | 000 |
| 07540194013378 | K211292 | 000 |
| 07540194013361 | K211292 | 000 |
| 07540194013354 | K211292 | 000 |
| 07540194013347 | K211292 | 000 |
| 07540194013330 | K211292 | 000 |
| 07540194013323 | K211292 | 000 |
| 07540194013187 | K211292 | 000 |